Years after News Tribune series, bed deaths continueAfter 81-year-old Clara Marshall badly bruised herself in a tumble from her bed at a care facility in Vancouver, Wash., the staff urged her husband to buy a metal siderail to protect her from another fall.
By: Lindsay Wise, McClatchy Washington Bureau
WASHINGTON — After 81-year-old Clara Marshall badly bruised herself in a tumble from her bed at a care facility in Vancouver, Wash., the staff urged her husband to buy a metal siderail to protect her from another fall.
The device had only been attached to the side of Marshall’s bed for about five weeks when she rolled over in March 2007 and her neck became stuck in the railing. Marshall, who suffered from dementia, suffocated and died.
Stunned by grief, Marshall’s daughter, Gloria Black, at first assumed her mother’s death was a freak accident.
It wasn’t. And the story isn’t new.
For years before and after Marshall’s death, thousands of frail, confused or elderly people have been injured and hundreds killed after becoming trapped in safety rails installed to keep them from falling out of bed.
A News Tribune investigation 15 years ago detailed the dangers of the siderails, finding at least seven patient deaths in Minnesota involving them between 1996 and 1998, and 74 deaths nationally in the three-year period before that.
The newspaper’s investigation revealed that federal regulators, nursing homes and bed manufacturers had known for decades of the hazards posed by siderails, yet beyond a warning by the U.S. Food and Drug Administration to nursing homes in 1995, little had been done to correct the problems.
Now, more than 20 years after the first of those deaths covered in the series, patients continue to die. A review of articles, court records and incident reports filed with federal or state agencies reveal some victims’ names and the disturbingly similar circumstances of their deaths:
“That is amazing to me that you can have a product sold in a medical supply store and no one has verified is this safe,” said Black, who now campaigns for mandatory safety standards for siderails — or preferably an outright ban.
Nationwide, nearly 37,000 people visited hospital emergency rooms and 155 people died because of injuries caused by adult portable siderails between 2003 and 2012, according to the Consumer Product Safety Commission. Most of the accidents occurred in private homes, nursing homes or assisted-living facilities. More than 80 percent of the victims were older than 60.
“It’s a horrible, tragic, painful, scary way to die, and it’s just so unnecessary,” said Steve Levin, a Chicago attorney who represents residents of long-term care facilities.
Levin says the number of fatal incidents and near-misses involving adult siderails is underreported. Elderly victims might not have any family, or even if they do, their relatives may not know where to report the incident. And sometimes siderail accidents are covered up by care facilities fearful of lawsuits or citations, he said.
In one case Levin worked on, a nursing home hid a bed and mattress after a patient strangled in the rails.
“If an elderly resident dies in bed it would not be difficult for a nursing home to attribute the cause of death to whatever medical conditions brought them to the nursing home,” he said.
Confidentiality clauses inserted into lawsuit settlements also obscure the extent of the problem by silencing families of siderail victims from sharing their personal stories, Levin said. “That creates a public safety issue,” he said.
Part of the problem is that deaths and injuries in the senior population tend to provoke less public outrage — and fewer calls for regulations or reform — than deaths and injuries of infants, said Robyn Grant, director of public policy and advocacy for National Consumer Voice for Quality Long-Term Care, a national consumer advocacy organization.
“I think there is a societal prejudice — call it ageism — but we focus more on youth and children in our society and not on elders,” Grant said.
Unlike children’s cribs and siderails, which must by law meet certain design criteria and pass safety tests, adult siderails are relatively unregulated.
Steven Miles, a professor of medicine at the University of Minnesota, first identified the trend of adult siderail accidents about two decades ago, leading the FDA to issue a safety alert for siderails associated with hospital beds in 1995.
In 1999, after the News Tribune’s series, government regulators and health-care industry representatives held meetings to forge a solution to the problem. To Miles, it was “a big step,” he said then, adding: “They’re finally putting all the stakeholders together in one room.”
But the effort yielded little beyond a non-legally binding guidance for hospital siderails issued in 2006, and an abandoned suggestion for required warning labels. Waiting for the government to take more meaningful action ever since, Miles said, “I haven’t started holding my breath.”
The FDA says voluntary guidance is “an efficient regulatory tool,” adding that reports of patient entrapment in siderails have decreased in recent years. But the agency admits there is a lack of research on the need and purpose of siderails.
“The FDA is concerned that the risk of serious injury to patients from siderails remains a problem, despite concerted efforts by federal agencies to mitigate hazards,” the agency said in response to written questions.
Some long-term care providers argue that rails can be a helpful tool if used properly, and that banning them completely could increase the risk of falls.
Golden Living, which runs Medicare- and Medicaid-certified nursing and assisted-living facilities in 21 states, said in comments posted in the Federal Register, that its centers use half-rails or assist rails in tandem with alternating pressure mattresses to reduce ulcers.
Candace Bartlett, Golden Living’s senior director of regulatory affairs, wrote in the comments that while caretakers must adhere to manufacturer guidelines, the government should “avoid rulemaking which would eliminate their use altogether.”
Recently, pressure from Black, consumer groups and members of Congress have refocused the government on the need for closer scrutiny of adult siderails, especially a portable version intended for use with an ordinary home-style bed, rather than a hospital bed. Since portable siderails typically aren’t considered medical devices, the FDA guidelines for hospital siderails don’t apply to them.
Yet portable rails are particularly dangerous, Miles said.
Consumers can get easily confused about how to install the devices safely, while staff at nursing homes and long-term care facilities sometimes mix and match them with mattresses that don’t fit or that compress easily, leaving a gap for the patient to fall into, Miles said.
“You wind up with these ad-hoc systems that really don’t work very well,” he said.
In April and May, consumer groups and patient advocates filed petitions with the federal government asking for a ban on adult portable siderails as “hazardous products” or for mandatory standards.
The next month, the Consumer Product Safety Commission joined with the FDA to announce that the two agencies would work together to address siderail safety with ASTM International, a nonprofit company that develops voluntary standards for more than 100 industry sectors, from steel to plastics.
The committee assigned to write the voluntary standards for adult portable siderails has about 70 participants, including consumer advocates, government officials, manufacturers and test labs, said Len Morrissey, director of technical committee operations for ASTM.
Morrissey doesn’t expect an official draft of voluntary standards to be ready before the end of October at the earliest, and a final version realistically won’t be ready for at least another year.
Black, who serves on the ASTM committee, is frustrated with the slow process, especially given how long it has taken just to get to this point.
“It’s really too bad how many more people will die this year in siderails while we are waiting for the standards process to get moving,” she said.
Duluth News Tribune staff contributed to this report.